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Intended Use: MAYFIELD® Radiolucent Skull Pins are used with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surqical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MRI imaging is used. Indications for Use: The MAYFIELD® Radiolucent Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MRI imaging of the patient is used.

The MAYFIELD Radiolucent Skull Pin 4-0-A-2020 [radiolucent pin] consists of the following components: a molded black-color ABS plastic base, and a machined sapphire-crystal pin point. The radiolucent pins are packaged three (3) pins per pouch, two (2) pouches per carton and EO sterilized. The radiolucent pins are single-use devices used to rigidly fix the patient's head and/or spine during surgery. The radiolucent pins are assembled from two components; a molded ABS plastic base [the same as used in the predicate device, MAYFIELD Disposable Skull Pins 4-0-A-1072][A1072 pins] and a pin point made of sapphire crystal that is machined to the same dimensions as the A1072 pin point. In preparation for surgery three (3) radiolucent pins are installed in a MAYFIELD Radiolucent Skull Clamp; two radiolucent pins in the Rocker Arm side and a single radiolucent pin on the opposite side. The radiolucent pins are EO sterilized, just as the A1072 pins mentioned above, and are ready for use right from the sterile pouch.

The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the sku!!, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

The devices are not changed either in hardware or software. They remain as shown in K955397, K982244, K991267, and K992843. This notification only relates to a revision of the Indications for Use to a closer alignment riflis notinoution only rolatoo to a rothfor the devices shown above to which Substantial Equivalence is claimed. All of these devices use CT or MRI data gathered prior to, or during, a surgery that is then correlated to the patient by way of various locating methods (mechanical, optical or ther concluded to the potware. This then allows the user to plan, and/or complete, the intended procedure.

The Systems are intended for use as: devices that, by the use of diagnostic images of the patient, acquired specifically to assist the surgeon with presurgical planning, provide orientation and reference information during intra-operative procedures. The Systems are indicated for use in: Guidance and localization in open craniotomies, and for surgeries that are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies, and electrode implants. The Systems may also be used to review medical images in a neurosurgical context.

The MAYFIELD®/ ACCISS™ Operating Arm System with Windows NT® for Cranial Surgery and MAYFIELD® Optical ACCISS™ System with Windows NT® for Cranial Surgery and with the Wireless Probe/DRF are modifications to existing systems. The modifications involve converting the operating system software to Windows NT from DOS and adding a battery-powered Wireless Probe and battery-powered Wireless Dynamic Reference Frame for use with the Optical System. The systems use diagnostic images of the patient for presurgical planning and provide orientation and reference information during intra-operative procedures. The systems utilize either arm or optical tracking for 3-D digitizing, interface to a computer graphics workstation, display reformatted CT or MR images, and use algorithms for image-guided surgery planning.

The MAYFIELD®/ ACCISS™ Image-guided Stereotactic Workstation and the MAYFIELD®/Optical ACCISS™ Image-guided Stereotactic Workstation (OASYS"), are indicated for use in guidance and localization in open craniotomies and in spinal surgeries. The ACCISS™ Systems are indicated for any medical condition in which the use of stereotactic surgery may be considered safe and effective, and where a reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.

Spine Applications is software that allows the user to select ("crop") images of the portion of the spine under consideration from images of the entire spinal column. Also included is an accessory, the MAYFIELD® ACCISS" Spine Ring" Assembly (hereafter referred to as Spine Ring). The indications for use of the Arm and Optical Systems have been expanded to include use in spinal surgeries. With Spine Applications, the Arm and Optical Systems can be used to identify spinal anatomical landmarks on the preoperative patient scans and also on the patient's spine to achieve registration with the imaged data set. After the correlation, the indication of the probe orientation appears on the monitor screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon. This is the same process as that used in cranial surgery with the Systems. Spine Applications, in conjunction with the Arm and Optical Systems, is a computer-based system designed for use in the surgical theatre. The Arm System uses a position-sensing articulated Arm with a probe that acts as a localizing device. The Optical System uses a Sensor Assembly positioned above/beside the surgical site that tracks the position and orientation of digitizing probes and other instruments. To use either System, the computer is loaded with the patient's computed tomography (CT) or magnetic resonance image (MRI) data and these images are correlated to the patient by physically matching points of anatomical landmarks. The System computer interfaces with CT or MR images and provides probe orientation/ probe-tip position. The indication of the probe orientation and probe-tip position appears on the monitor screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon.

The OMI® Occipital Cervical Loop is intended to be used to assist stabilization and fusion of the cervical spine and cervical occipital junction. 1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies). 2. Spondylolisthesis of the cervical vertebrae. 3. Spinal stenosis of the cervical vertebrae. 4. Atlanto/axial fracture with instability. 5. Cervical-occipital dislocation. 6. Revision of previous cervical fusion surgery. 7. Tumors.

The OMI® Occipital Cervical Loop, Catalog Number A-1089, consists of the following components: Cervical Support Loop, Cross Link, Compression Blocks (2), Cervical Support Nuts (2), and an implantation instrument, the Cervical Support Wrench [11mm]. The OMI® Occipital Cervical Loop is a single-use, permanent device used to assist in stabilization and fusion of the occipital cervical region of the spine. It consists of the Cervical Support Loop [CSL], a contoured rod made of biocompatible titanium having an alloy composition of 6AL-4V ELI, according to ASTM-F136. The CSL is U-shaped, with a circular loop at one end and two free lengths extending lengthwise, parallel to each other, from the loop end. The profile of the CSL resembles that of a normal cervical lordosis from the cervical region of the spine to the occiput of the skull. The Cross Link can be attached to the free end lengths of the CSL for additional rigidity. The Cross Link is flat, with a slot at each end, and can be attached to the CSL with the Compression Blocks and Cervical Support Nuts. The Cross Link, Compression Blocks, and Cervical Support Nuts are also made from 6AL-4V ELI titanium. These titanium alloy implants are designed for use with multi-filament braided titanium alloy [6Al, 4V] cable, .045 inch [1.1 mm] diameter, 19 inches in length, with a pure, soft titanium mono-filament lead wire 3 inches in length. This wire is Sofamor Danek Catalog # 826-360, the same type of wire cleared for use with Sofamor/Danek spinal devices.

Intended Use: The Optical Tracking ACCISS™ System is intended to be used in an identical manner as the predicate device (Mayfield®/ACCISS™ Stereotactic Workstation). It is used for guidance and localization in open craniotomies and for surgeries, which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.

The Optical Tracking ACCISS™ System is a computer-based system designed for use in the surgical theatre. It is a mobile design with the majority of the system components being self-contained in a cart. The camera assembly is separate from the cart components and it must be positioned above or beside the surgical site, preferably on a tripod or dedicated camera stand. The camera assembly tracks the position and orientation of digitizing probes and other instruments. The computer is loaded with the patient's computed tomography (CT) or magnetic resonance image (MRI) data and these images are correlated to the patient by physically matching points, such as scanned fiducial markers, anatomical landmarks, or surface features. The host computer, interfaced with CT and /or MRI images, provides probe position and orientation. The probe manipulation by the surgeon appears on a monitor as it moves through space. Three light-sensing cameras, the positions of which are known with respect to a predetermined coordinate system, detect the positions of at least two light-emitting diodes positioned on the probe. The cameras and probe transmit data to a computer and the position and orientation of the probe is determined relative to the coordinate system. The probe tip position is determined by correlating the tip position with the position of a scanned image of the object, both tip position and scanned image being defined relative to the predetermined coordinate system. A monitor connected to the computer indicates the location of the probe tip on the scanned image by displaying a representative location of the tip with respect to the model of the object. The Optical Tracking ACCISS™ System consists of the following: A. Workstation B. Software C. Probe Assembly D. Training Accessories (1) Plastic Skull 50 CT/MRI Fiducial Markers

The TEW Cranial Spinal Retractor (A-1090) is designed for posterior fossa or intraspinal microsurgery where retraction is required.

TEW Cranial/Spinal Retractor™ is made from titanium and the blades, micro-retractors and flexarm assemblies are made from stainless steel. It has two movable arms, which operate independently by rotating a worm on a worm gear thus allowing an acme threaded shaft to translate through the worm gear (Patent pending). The mechanism of the TEW Retractor is self locking due to the worm/worm gear design. A hex wrench is used to drive the system. TEW Retractor blades can be pre-attached to the arms outside of the wound and a formed locking edge on the blades prevent them from falling off. The blades can also be pre-positioned and once retraction has been initiated, blades will remain in a fixed position. TEW Retractor micro-retraction is accomplished by unrestricted placement of the flexarm assemblies along the entire length of the retractor arms. There is no limit to the number of flexarms that can be used.